Last Review Date: 03/02/2023

Date of Origin:  08/26/2014

Dates Reviewed:  08/2014, 07/2015, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 05/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020, 03/2021, 03/2022, 03/2023

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Beleodaq 500 mg powder for injection: 25 vials per 21 days

2. Max Units (per dose and over time) [HCPCS Unit]:

• All indications: 1,250 billable units every 21 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ^1,2

• Used as a single agent; AND

T-Cell Lymphomas ^1-4

• Peripheral T-Cell Lymphoma (PTCL) † ‡ Ф ^1-4

(Including: Angioimmunoblastic T-cell lymphoma ‡; Peripheral T-cell lymphoma not otherwise specified ‡; Anaplastic large cell lymphoma ‡; Enteropathy-associated T-cell lymphoma ‡; Monomorphic epitheliotropic intestinal T-cell lymphoma ‡; Nodal peripheral T-cell lymphoma with TFH phenotype ‡; or Follicular T-cell lymphoma ‡)

• • Used as subsequent therapy for relapsed or refractory disease; OR
  • Used as initial palliative intent therapy
• Adult T-Cell Leukemia/Lymphoma ‡ ²
  • Used as subsequent therapy for non-responders to first-line therapy for acute or lymphoma subtypes
• Extranodal NK/T-Cell Lymphomas (Nasal Type) ‡ ²
  • Patient has relapsed or refractory disease; AND
  • Patient has previously received additional therapy with an alternate combination chemotherapy regimen (asparaginase-based) not previously used
• Hepatosplenic T-Cell Lymphoma ‡ ^2,4
  • Used as subsequent therapy for refractory disease after two first-line therapy regimens
• Breast Implant-Associated Anaplastic Large Cell Lymphoma (ALCL) ‡ ²
  • Used as subsequent therapy for relapsed or refractory disease

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,4,5

Coverage may be renewed based upon the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: hematologic toxicity (e.g., thrombocytopenia, leukopenia, and/or anemia), severe infections, hepatotoxicity, tumor lysis syndrome, severe gastrointestinal toxicity, etc.

5. Dosage/Administration ^1,3,4

   Indication	Dose
   All indications	Administer 1,000 mg/m² intravenously daily on days 1-5 of a 21-day cycle until disease progression or unacceptable toxicity.

6. Billing Code/Availability Information

       HCPCS Code:

• J9032 - Injection, belinostat, 10 mg; 1 billable unit = 10 mg

NDC:

• Beleodaq 500 mg single-dose vial (30 mL): 72893-0002-xx

7. References

1. Beleodaq [package insert]. East Windsor, NJ; Acrotech Biopharma LLC; April 2022. Accessed February 2023.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) for belinostat. National Comprehensive Cancer Network, 2023. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES^® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed February 2023.
3. O'Connor OA, Masszi T, Savage KJ, et al. Belinostat, a novel pan-histone deacetylase inhibitor (HDACi), in relapsed or refractory peripheral T-cell lymphoma (R/R PTCL): Results from the BELIEF trial. Journal of Clinical Oncology 2013 31:15_suppl, 8507-8507.
4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for T-Cell Lymphomas 1.2023. National Comprehensive Cancer Network, 2023. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Guidelines, go online to NCCN.org. Accessed February 2023.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA): N/A